RecruitingNot ApplicableNCT07305519

The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth:

The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth: A Randomized Controlled Trial

Sponsor

University of Roma La Sapienza

Enrollment

150 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Preterm Labor

Summary

The aim of the study is to assess the effect of a combination of Magnesium, Palmitoylethanolamide, high-molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in women at risk of preterm birth (PTB).

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

Signed informed consent
Singleton pregnancy
Maternal age ≥ 18 years
Gestational age between 20+0 and 34+0 weeks at enrollment
Cervical length between 15 mm and 30 mm measured by transvaginal ultrasound

Exclusion Criteria5

Fetal structural anomalies
Maternal chronic diseases or pregnancy-related conditions, including diabetes, hypertension, preeclampsia, cardiovascular disease, infections, or autoimmune disorders
Multiple gestation
Fetal growth abnormalities (estimated fetal weight <10th or >90th percentile)
Prelabor rupture of membranes (PROM)

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Interventions

DRUGMagnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone

Participants randomized to the treatment arm will receive a combination oral supplement containing Magnesium (450 mg), Palmitoylethanolamide (200 mg), high-molecular-weight Hyaluronic Acid (200 mg), Vitamin B6 (2.6 mg), and Vitamin D (50 µg / 2000 IU), administered as two tablets per day. The supplement will be given in addition to standard vaginal progesterone (200 mg once daily). Treatment begins at enrollment (20-34 weeks' gestation) and continues until 37 weeks of gestati

OTHERStandard Treatment (Guideline-Based)

Participants randomized to the control arm will receive standard therapy consisting of vaginal progesterone (200 mg once daily) from enrollment (20-34 weeks' gestation) until 37 weeks of gestation. No additional supplements or investigational products will be administered.